Regulatory requirements for in-house IVDs
Version 2.0, March 2016
Electronic application form for submitting Class 1-3 in-house IVD notifications now available
Class 1-3 In-house IVD Notification Form is now available online through TGA Business Services. Before your organisation uses TGA Business Services for the first time, you need to apply for a client identification number. For help with using TGA Business Services, including resetting your password, go to TGA Business Services - how to use this site.
The transition period for in-house IVDs ends on 30 June 2017. Laboratories must comply with the regulatory requirements and notify the TGA of their Class 1-3 in-house IVDs by 1 July 2017.
The definition of what constitutes an in-house IVD medical device (IVD) and the regulatory requirements for continued use of the IVD after 1 July 2017 can be found within this guidance document.
In order to access the online notification form, it is recommended that laboratories apply as soon as possible for an Organisation ID and access to the TGA Business Services portal in preparation for submitting your notification by 1 July 2017. This can be done by completing the Organisation Details form and submitting it to firstname.lastname@example.org
For assistance with accessing and completing the notification for within the TGA Business Services portal, please refer to our online guidance.
If you have any queries regarding notification of Class 1-3 in-house IVDs, please contact us: email@example.com
Australian laboratories that manufacture in-house in vitro diagnostic medical devices (IVDs) are required to meet regulatory requirements (that commenced on 1 July 2010) to legally supply* their IVDs in Australia.
The IVD regulatory framework has the following features:
- IVDs must comply with a set of essential principles for the quality, safety and performance of the IVD.
- A risk-based classification scheme requiring different levels of regulation for each class of device.
- There are a choice of procedures (known as conformity assessment procedures), based on the risk classification, to be applied by manufacturers to demonstrate initial and on-going compliance with the essential principles.
- Compliance with recognised standards is used as a means to demonstrate that the essential principles and conformity assessment procedures have been met.
- It includes provisions for post market activities, including monitoring and adverse event reporting.
Laboratories, the Therapeutic Goods Administration (TGA) and the National Association of Testing Authorities (NATA) are involved in ensuring the regulatory requirements of in-house IVDs are met.
This guidance explains how laboratories that manufacture in-house IVDs can meet these requirements.
* Supply means making the test available to clinicians and reporting results of the test.